Sympatholysis in Chronic Kidney Disease

Last updated: March 3, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

1

Condition

Nephropathy

Kidney Disease

Kidney Failure

Treatment

Sodium Bicarbonate

Exercise Training

Control to Exercise (Stretching)

Clinical Study ID

NCT02411773
IRB00078214
2R01HL135183
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Veterans with Stages III and IV Chronic Kidney Disease (CKD)

  • Kidney transplant recipients with varying degrees of kidney function

  • Veterans 18-75 years old, without kidney disease, as study controls

  • Exercise less than 20 minutes twice per week

  • Willing and able to cooperate with the protocol

Exclusion

Exclusion Criteria:

  • Severe CKD (estimated glomerular filtration rate (eGFR) < 15 cc/minute)

  • Metabolic alkalosis (serum bicarbonate > 28 meq/L)

  • Ongoing drug or alcohol abuse

  • Diabetic neuropathy

  • Any serious systemic disease that might influence survival

  • Severe anemia with hemoglobin (Hbg) level < 10 g/dL

  • Clinical evidence of congestive heart failure or ejection fraction below 35%

  • Symptomatic heart disease determined by prior electrocardiogram, stress test, and/orhistory

  • Treatment with central alpha agonists (clonidine)

  • Uncontrolled hypertension with blood pressure (BP) greater than 170/100 mmHg

  • Low blood pressure with BP less than 100/50 mmHg

  • Pregnancy or plans to become pregnant

  • Current treatment with monoamine oxidase inhibitors (MAOIs)

  • Inability to exercise on a stationary bicycle

Study Design

Total Participants: 110
Treatment Group(s): 4
Primary Treatment: Sodium Bicarbonate
Phase: 1
Study Start date:
June 11, 2015
Estimated Completion Date:
June 30, 2027

Study Description

Patients with chronic kidney disease (CKD) suffer from exercise intolerance and poor physical capacity which contributes to increased cardiovascular risk in this patient population. Prior studies have shown that CKD patients have an exaggerated increase in blood pressure (BP) during both static and rhythmic exercise. Such abnormal hemodynamic responses to exercise can contribute to poor physical capacity and abnormal muscle blood flow during exercise in these patients. The goals of this project are to investigate the mechanisms and potential therapies targeting the abnormal hemodynamic response during exercise in CKD by examining the roles of impaired vasodilation, and exaggerated vasoconstriction.

Connect with a study center

  • Atlanta VA Medical Center

    Decatur, Georgia 30033
    United States

    Active - Recruiting

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